Common use of Product Specifications; Packaging and Labeling Clause in Contracts

Product Specifications; Packaging and Labeling. All Products delivered by Seller hereunder shall be in full compliance with the Specifications therefor and shall be ready for end-user sale, including all packaging, labeling, instructions-for-use and sterilization set forth therein, as amended. All Products shall be labeled (including bar coding/UPN numbers) in accordance with the work instructions, procedures and label text/graphics specified in writing from time to time by Buyer and mutually approved by Buyer and Seller. Buyer shall give Seller at least ** ** advance written notice of any change to its labeling procedures prior to the date when such changes are to take affect. Notwithstanding anything in this Agreement to the contrary, Buyer shall pay Seller for ** ** Reimbursements, as set forth in Section 2.3 above. All Products will be marked to make it clear that they have been manufactured by Seller and are being distributed by Buyer. Buyer may include Product as a component in any kit or collection of products. Buyer maintains the right to over-label Products as it deems necessary or appropriate in accordance with work instructions, procedures, and label text/graphics, which are mutually approved by both Parties hereto. Seller is not responsible for any over-labeling or any consequences thereof. As used in this Agreement, “Specifications” for the Product means the specifications set forth on Exhibit A, as revised from time to time pursuant to the next sentence, and as provided by Seller and approved by Buyer, including the part number, revision level, controlled drawing, and packaging and sterilization instructions for the Product and all requirements of any applicable laws and regulations of the Regulatory Authorities, specified therein. The Parties understand that the Specifications may need to be revised from time to time up to the Product Launch Date. Each version (each, a “Revision Level”) of the Specifications will be labeled with a Revision Level number (“Revision Level Number”), starting with “A-1,” and continuing sequentially with “A-2,” “A-3,” etc., and each revision of the Specifications will be so labeled and attached to this Agreement. Each subsequent Revision Level will replace and supersede all former Revision Levels for all purposes hereunder, except with respect to Article 4 of this Agreement. Attached to this Agreement as Exhibit A as of the Effective Date is Revision Level “A-1.”

Product Specifications; Packaging and Labeling. All Products delivered by Seller hereunder shall be in full compliance with the Specifications therefor and shall be ready for end-user sale, including all packaging, labeling, instructions-for-use and sterilization set forth therein, as amended. All Products shall be labeled (including bar coding/UPN numbers) in accordance with the work instructions, procedures and label text/graphics specified in writing from time to time by Buyer and mutually approved by Buyer and Seller. Buyer shall give Seller at least ** ** thirty (30) days advance written notice of any change to its labeling procedures prior to the date when such changes are to take affect. Notwithstanding anything in this Agreement to the contrary, Buyer shall pay Seller for ** ** Waste Reimbursements, as set forth in Section 2.3 above. All Products will be marked to make it clear that they have been manufactured by Seller and are being distributed by Buyer. Buyer may include Product as a component in any kit or collection of products. Buyer maintains the right to over-label Products as it deems necessary or appropriate in accordance with work instructions, procedures, and label text/graphics, which are mutually approved by both Parties hereto. Seller is not responsible for any over-labeling or any consequences thereof. As used in this Agreement, “Specifications” for the Product means the specifications set forth on Exhibit A, as revised from time to time pursuant to the next sentence, and as provided by Seller and approved by Buyer, including the part number, revision level, controlled drawing, and packaging and sterilization instructions for the Product and all requirements of any applicable laws and regulations of the Regulatory Authorities, specified therein. The Parties understand that the Specifications may need to be revised from time to time up to the Product Launch Date. Each version (each, a “Revision Level”) of the Specifications will be labeled with a Revision Level number (“Revision Level Number”), starting with “A-1,” and continuing sequentially with “A-2,” “A-3,” etc., and each revision of the Specifications will be so labeled and attached to this Agreement. Each subsequent Revision Level will replace and supersede all former Revision Levels for all purposes hereunder, except with respect to Article 4 of this Agreement. Attached to this Agreement as Exhibit A as of the Effective Date is Revision Level “A-1.”